enVVeno Medical Corporation.
NVNO.US | Manufacture of medical and dental instruments and supplies
enVVeno Medical Corporation is a medical technology company focused on developing innovative bioprosthetic (tissue-based) valve technologies to improve the standard of care for venous disease. The company's lead product is the enVVe(TM) bioprosthetic valve, a surgically implanted valve designed to t...Show More
Better Health for All
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The company's principal products, the VenoValve and enVVe, are investigational medical devices designed to treat severe deep Chronic Venous Insufficiency (CVI).
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While interim two-year clinical trial data for VenoValve showed sustained clinical improvement, with 83% of subjects maintaining a clinically meaningful benefit, a median 74% improvement in leg pain, and 60% of ulcers healing completely, the FDA issued a not-approvable letter for the VenoValve's Premarket Approval application in August 2025.
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The FDA cited insufficient data to determine a favorable benefit-risk profile, concerns about bias due to a lack of specific hemodynamic measurements correlating with patient improvement, and safety concerns attributed to the VenoValve's open surgical procedure requiring re-hospitalizations.
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The company is investing in the development of both surgical and non-surgical venous valves.
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These products are targeted at 2.5 to 3.5 million U.S. patients suffering from severe deep venous CVI who currently lack effective treatment options.
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The VenoValve is only available for use in the U.S. in pre-market clinical studies, and the FDA's concerns about bias in clinical improvement data and safety issues with the surgical procedure indicate significant ethical and safety challenges in the clinical trial process.
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Fair Money & Economic Opportunity
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enVVeno Medical Corporation is a medical technology company focused on developing bioprosthetic valve technologies.
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Its core business involves medical devices, not lending, insuring, moving, or storing money for consumers.
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Therefore, all KPIs related to fair money and economic opportunity, which are specific to financial services, are not applicable to its operations. No evidence in the provided articles suggests the company engages in any activities relevant to these financial services-focused KPIs.
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Fair Pay & Worker Respect
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The company reported no collective bargaining agreements in 2023
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and 0% of its employees covered by such agreements as of March 24, 2022.
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There is no evidence of active union-busting tactics or other negative actions.
Fair Trade & Ethical Sourcing
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No evidence was found in the provided articles to assess enVVeno Medical Corporation against the 'Fair Trade & Ethical Sourcing' ethical value. The articles primarily contain financial data, regulatory information regarding medical devices, and an internal code of conduct, none of which provide specific, concrete data points for any of the defined KPIs related to fair trade certifications, supplier audits, forced/child labor incidents, supply chain traceability, remediation speed, ethical clause coverage in supplier contracts, materials risk, or supplier diversity spend.
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Honest & Fair Business
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The company adopted a Code of Conduct on October 31, 2017, which requires directors, officers, and employees to report suspected violations and explicitly prohibits retaliation against those who make good faith reports.
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The Code outlines reporting channels to supervisors, the Chief Executive Officer, or the Audit Committee.
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The company also has an insider trading policy and a clawback policy adopted in accordance with Nasdaq rules and Rule 10D-1.
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The Code promotes compliance with applicable governmental laws, rules, and regulations, and fair dealing practices.
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However, the policy does not detail specific anti-corruption guidance for international or high-risk markets, nor does it provide information on training frequency or effectiveness metrics for its anti-corruption measures.
Kind to Animals
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The company, enVVeno Medical Corporation, has completed animal testing for its enVVe™ bioprosthetic valve.
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However, the provided articles do not offer specific quantitative data regarding the volume of animals used, the company's animal testing policy, or its engagement with alternative testing methods. There is also no information available on cruelty-free certifications, ethical sourcing, wildlife conservation, or any other animal welfare initiatives directly attributable to NVNO.US.
No War, No Weapons
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The provided articles consistently describe enVVeno Medical Corporation as a medical technology company focused on developing bioprosthetic valve technologies for venous disease.
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The articles do not contain any information, positive or negative, regarding the company's involvement in arms manufacturing, military contracts, dual-use technologies, sales to embargoed regimes, peacebuilding investments, or any other conflict-related activities.
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Therefore, all KPIs related to the 'No War, No Weapons' value are omitted due to a lack of explicit evidence in the provided materials.
Planet-Friendly Business
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No sustainability data, quantitative information, regulatory actions, or certifications were available for NVNO.US in the provided article.
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Therefore, no KPIs could be assessed against the Planet-Friendly Business value.
Respect for Cultures & Communities
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The provided article, the OutQUORUM 2024 report, focuses on LGBTQ+ inclusive board diversity policies and board member demographics across major global indices.
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It explicitly states that no data specific to NVNO.US or the ethical value 'Respect for Cultures & Communities' is included.
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Furthermore, the report explicitly confirms the absence of quantitative data for all relevant KPIs, including reinvestment in local communities, cultural appropriation incidents, cultural impact assessments, local employment, grievance mechanisms, FPIC participation, community governance inclusion, cultural preservation investment, local procurement, indigenous supplier count, cultural site protection, social license operations, charitable giving, community fund allocation, language inclusivity, cultural incident response, and cultural training completion.
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Therefore, there is no evidence to assess NVNO.US against any of the defined KPIs for this value.
Safe & Smart Tech
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No incidents of unauthorized data use have been documented in the provided articles.
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The company mentions two-factor authentication, monitoring of systems and user accounts, and improved password rules, indicating standard authentication and vulnerability management practices.
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There is no information available regarding a bug bounty program, which aligns with a basic or no program.
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The company is subject to FDA regulations for medical devices, including PMA and IDE processes, and mentions compliance with these regulations.
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Zero Waste & Sustainable Products
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No evidence was found in the provided articles to assess NVNO.US against any of the 'Zero Waste & Sustainable Products' KPIs. The articles either explicitly state a lack of relevant data for NVNO.US
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or discuss unrelated topics.
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